Protocol for the evaluation of delamination problems

delaminazione

 

The term “delamination” refers to the phenomenon of detachment of glass flakes from the glass surface with the risk of formation of particles in suspension (flakes), which in the case of parenteral use may involve a risk to the health of the patient.

Stazione Sperimentale del Vetro, based on the specifications of the USP 1660 standard “Evaluation of the Inner surface durability of glass containers”, has developed an analysis protocol to verify the propensity to delamination of glass for pharmaceutical use.

The assessment can be performed either on containers filled with the pharmaceutical formulation, after an appropriate period of contact, or on new containers subjected to accelerated stability tests, performed using specific simulants or even the pharmaceutical formulation itself.

2019-01-15T22:06:39+00:00